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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, drainage, suprapubic
Regulation Description Suprapubic urological catheter and accessories.
Product CodeFFA
Regulation Number 876.5090
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 74
Difficult to remove 31
Tear, rip or hole in device packaging 15
Foreign material present in device 14
Device damaged prior to use 10
Fracture 10
Detachment of device component 8
Entrapment of device or device component 7
Kinked 6
Sticking 6
Unsealed device packaging 6
Migration of device or device component 6
Device, or device fragments remain in patient 6
Bent 4
Device packaging compromised 4
Component(s), broken 4
Detachment of device or device component 4
Difficult to position 3
Leak 3
Calcified 3
Failure to advance 3
Tip breakage 2
No Known Device Problem 2
Difficult to deploy 2
Occlusion within device 2
Dislodged or dislocated 2
Dislodged 2
Peeled 2
Device Issue 2
Material separation 2
Packaging issue 2
Split 2
Difficult to open or remove packaging material 2
Device or device fragments location unknown 2
Torn material 2
Defective item 2
Material perforation 1
Delivery system failure 1
Fluid leak 1
Positioning Issue 1
Difficult to advance 1
Malposition of device 1
Hole in material 1
Catheter withdrawal interference 1
Air leak 1
Wire(s), breakage of 1
Shaft break 1
Material deformation 1
Unintended movement 1
Knotted 1
Shipping damage or problem 1
Use of Device Issue 1
Degraded 1
Melted 1
Failure to deliver 1
Twisting 1
Regenerate 1
Material discolored 1
Defective component 1
Sterility 1
Material disintegration 1
Device operates differently than expected 1
Tears, rips, holes in device, device material 1
Uncoiled 1
Physical resistance 1
Foreign material 1
Total Device Problems 287

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II May-21-2009

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